Senior Manager Analytical Development

Lundbeck•Bothell, WA

About The Position

Lundbeck Seattle Biopharmaceuticals is seeking a highly motivated and experienced scientific leader to manage the Characterization and Development team within the Analytical Development department. This role includes responsibility for mass spectrometry, characterization, comparability and forced degradation studies of biotherapeutic molecules to support process development and changes to clinical and marketed products. The characterization team includes analytical leads supporting Lundbeck biologics programs, and this role will also serve as an analytical lead as needed. This role will support development programs through execution of analytical strategies, including Critical Quality Attribute (CQA) identification and assessment. The successful candidate will have demonstrated leadership in analytical characterization of biologics, including a strong familiarity with the use of mass spectrometry as applied to biologics. Knowledge of protein biochemistry, enzymology, chromatography, N- and O-linked glycosylation, cell biology, biophysical characterization, and proteomics as they pertain to biologics will also be beneficial. This role operates within a matrixed team structure, contributing to management of the Potency team in Analytical Development.

Requirements

PhD in Biochemistry, Chemistry, Biological Science, or related field with a minimum of 5+ years relevant experience
Experience building high-performing teams
Proven ability to manage performance, provide feedback, and drive accountability
Experience managing or mentoring scientists while remaining technically hands-on
Experience serving as an analytical lead or contributing to CMC teams
Working knowledge of Critical Quality Attributes (CQAs) and characterization strategies
Deep expertise in mass spectrometry for biologics (intact mass, peptide mapping, PTM analysis)
Strong understanding of biologics characterization and analytical method development
Experience working in a matrixed organization is preferred
Strong communication and collaboration skills

Nice To Haves

Knowledge of biologics CMC development from pre-clinical through clinical to commercialization
Experience in supporting regulatory submissions
Experience using mass spectrometry for identification and quantification of sequence variants (e.g., misincorporation), host cell proteins and N-glycan analysis/mapping
Prior Leadership training would be beneficial

Responsibilities

Manage and develop a team of scientists, including coaching, mentoring, and performance management
Directly contribute to experimental design, data analysis, troubleshooting, and interpretation of mass spectrometry data
Provide hands-on technical expertise in LC-MS-based characterization of biologics, including intact mass, peptide mapping, PTMs, sequence variant, HCP, and glycosylation analysis
Design, develop, and implement analytical methods for biologics characterization and routine testing
Serve as an analytical lead for biologics programs as needed, contributing to analytical strategy within cross-functional CMC teams
Contribute to CQA identification, risk assessment, and characterization activities
Lead and execute characterization, comparability, and forced degradation studies
Author and review methods, protocols, reports, and regulatory documentation
Collaborate closely with cross-functional teams to support development activities and timelines
Operate effectively within a matrix organization, supporting shared resources
Provide administrative matrix management for assigned potency team members, including performance input and formal reviews, in alignment with potency scientific leadership
Support transfer of analytical methods to external labs and review data as needed
Identify and implement improvements to analytical workflows and technologies as appropriate